The safety and pharmacokinetics of rapid iloprost aerosol delivery via the BREELIB nebulizer in pulmonary arterial hypertension

PVRI Member Authors: Ardeschir Ghofrani, Horst Olschewski, Stephan Rosenkranz, Werner Seeger

Abstract

The BREELIB nebulizer was developed for iloprost to reduce inhalation times for patients with pulmonary arterial hypertension (PAH). This multicenter, randomized, unblinded, four-part study compared inhalation time, pharmacokinetics, and acute tolerability of iloprost 5 µg at mouthpiece delivered via BREELIB versus the standard I-Neb nebulizer in 27 patients with PAH. The primary safety outcome was the proportion of patients with a maximum increase in heart rate (HR) ≥ 25% and/or a maximum decrease in systolic blood pressure ≥ 20% within 30 min after inhalation. Other safety outcomes included systolic, diastolic, and mean blood pressure, HR, oxygen saturation, and adverse events (AEs). Median inhalation times were considerably shorter with BREELIB versus I-Neb (2.6 versus 10.9 min; n = 24). Maximum iloprost plasma concentration and systemic exposure (area under the plasma concentration–time curve) were 77% and 42% higher, respectively, with BREELIB versus I-Neb. Five patients experienced a maximum systolic blood pressure decrease ≥ 20%, four with BREELIB (one mildly and transiently symptomatic), and one with I-Neb; none required medical intervention. AEs reported during the study were consistent with the known safety profile of iloprost. The BREELIB nebulizer offers reduced inhalation time, good tolerability, and may improve iloprost aerosol therapy convenience and thus compliance for patients with PAH.

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Topics

Pharmacology: Pharmacokinetics and Pharmacodynamics
Pulmonary Arterial Hypertension

Authors

Tobias Gessler, Hossein-Ardeschir Ghofrani, Matthias Held, Hans Klose, Hanno Leuchte, Horst Olschewski, Stephan Rosenkranz, Lueder Fels, Na Li, Dawn Ren, Andreas Kaiser, Marcus-Hillert Schultze-Mosgau, Bernhard Müllinger, Beate Rohde, Werner Seeger

Published in:

Pulmonary Circulation Vol 7: No 2 cover image

May 2017

Pulmonary Circulation Vol 7: No 2

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